Jubilant Life Sciences shares plunge after FDA warning for US plant
- Congress says Togadia spreading venom; EC seeks recording of alleged hate speech
- Proponents of Article 370 should say how it has helped J&K: Rajnath Singh
- 1984 riots: Akalis protest over Capt Amarinder Singh's clean chit to Jagdish Tytler
- Supreme Court issues notice to Goa Police, agrees to hear Tejpal's bail plea in sexual assault case
- IPL 7 Live Cricket Score, CSK vs DD: CSK win toss, elect to bat first
Indian drugmaker Jubilant Life Sciences Ltd said on Thursday it had received a warning from the U.S. Food and Drug Administration over manufacturing practices at one of its U.S. facilities, sending its shares the limit-down 10 percent.
The FDA said it could withhold approval of new products from Jubilant HollisterStier LLC, a facility located at Spokane, Washington, until the company takes action to comply with the regulator's good manufacturing practices, Jubliant Life Sciences said.
Jubilant HollisterStier will respond to the warning on or before December 12 and will take corrective actions to ensure compliance with the FDA, it added.
The facility accounted for 7 per cent of Jubilant Life Science's consolidated sales in the six months ended September.
Shares of Jubilant Life Sciences plunged 10 percent after the announcement, their steepest one-day fall in nearly six months, while the main Mumbai market was up 1.6 percent.
"We expect that the on-going manufacturing, distribution and sale of products from this facility will not be impacted as the WL (warning letter) will affect new approvals only," the company said in a statement.
Indian medicine makers, which produce nearly 40 percent of generic and over-the-counter drugs for the United States, have recently been battered by a rash of regulatory actions, including a record fine for Ranbaxy Laboratories Ltd and what amounts to a ban by the FDA on a second plant for Wockhardt Ltd.
Jubilant Life Sciences, which makes generics and provides contract manufacturing services, has 10 facilities in India, the United States and Canada.
- 21-year-old dies in road mishap, one injured
- Ask Badals where is Ludhiana Metro: Bhattal to locals
- Arrests in priest murder case divide Catholic Church
- Short Change: EPFO to allot permanent account number to active subscribers by Oct 15
- India Inc profit set to grow, but margins under pressure
- Mulayam: Will amend Constitution for Muslim quota